BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 5000992 · Received August 13, 2015

    Report

    Report Number
    2953200-2015-01297
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: PERIGRAFT PLUG EMBOLIZATION OF THE INTERNAL ILIAC ARTERY AND IMPLANTATION OF A BIFURCATED STENTGRAFT: ONE TREATMENT OPTION FOR INSUFFICIENT TUBULAR STENT GRAFT REPAIR OF A COMMON ILIAC ARTERY ANEURYSM JAN PETER GOLTZ, JULIA LOESAUS, ALEX FRYDRYCHOWICZ, JORG BARKHAUSEN, MARCUS WIEDNER (CARDIOVASC INTERVENT RADIOL 2015, DOI 10.1007/S 00270-015-1161-9) AN UNKNOWN STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ILIAC ARTERY ANEURYSM REPAIR. ࠔHE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK DUE TO INSUFFICIENT PROXIMAL LANDING ZONE. ABSTRACT WE REPORT AN ENDOVASCULAR TECHNIQUE FOR THE TREATMENT OF TYPE IA ENDOLEAK AFTER A PLAIN TUBULAR STENTGRAFT HAD BEEN IMPLANTED FOR A LARGE COMMON ILIAC ARTERY ANEURYSM WITH AN INSUFFICIENT PROXIMAL LANDING ZONE AND WITHOUT OCCLUSION OF THE HYPOGASTRIC IN ANOTHER HOSPITAL. CT FOLLOWUP SHOWED AN ENDOLEAK WITH CONTINUOUS SAC EXPANSION OVER 12 MONTHS. THIS WAS CLASSIFIED AS TYPE IA BY MEANS OF DYNAMIC CONTRAST-ENHANCED MRI. BEFORE A BIFURCATED STENTGRAFT WAS IMPLANTED TO RELOCATE THE LANDING ZONE MORE PROXIMALLY, THE STILL PERFUSED IPSILATERAL HYPOGASTRIC ARTERY WAS EMBOLIZED TO PREVENT A TYPE II ENDOLEAK. A GUIDEWIRE WAS MANIPULATED ALONGSIDE THE INDWELLING STENTGRAFT. THE INTERNAL ILIAC ARTERY COULD THEN BE SELECTIVELY INTUBATED FOLLOWED BY SUCCESSFUL PLUG EMBOLIZATION OF THE VESSEL'S ORIFICE DESPITE THE STENTGRAFT BEING IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534315 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA UNK-CV-SR-TAL TAA

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention